Senior Quality Assurance Engineer

GForce Life Sciences; Mahwah (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

GForce Life Sciences in Mahwah, NJ is seeking a Senior Quality Assurance Engineer to provide quality engineering support across QA, control, and preventative activities with a focus on EU-MDR initiatives for our medical device product portfolio.

The ideal candidate will have a Bachelor’s degree in engineering, 4+ years of industry experience, experience with EU-MDR programs, and excellent English communication skills to collaborate across functions and ensure robust compliance.

Qualifications

• Bachelor’s degree in an engineering field (Biomedical/Mechanical preferred).
• 4+ years of industry experience in quality assurance/quality engineering.
• Experience supporting EU-MDR programs/initiatives.
• Excellent English (oral and written).

Responsibilities

• Provide quality engineering support for EU-MDR initiatives across product portfolio.
• Develop and implement methods for process control, improvement, testing, and inspection.
• Support First Article Inspection (FAI) strategy and approvals.
• Support Production Part Approval Process (PPAP) activities.
• Support change control and perform change impact assessments.
• Maintain SOP and risk documentation updates and reviews.
• Support equipment and process validations.
• Lead initiatives to enhance quality performance and regulatory compliance.

Skills

Quality engineering

Process improvement

Regulatory experience

Education

Bachelor’s degree in engineering

Tools

FMEA

CAPA

PPAP

Job description

Our client, a leading medical device company, has engaged GForce Life Sciences to provide a Senior Quality Assurance Engineer. This role provides quality engineering support across quality assurance, control, and preventative activities within operations and other business functions, with a focus on EU-MDR initiatives for a portfolio of products.

Responsibilities

• Provide quality engineering support for EU-MDR initiatives across a product portfolio.
• Develop and implement methods and procedures for process control, process improvement, testing, and inspection to support product compliance and performance.
• Support First Article Inspection (FAI) strategy development, execution, and approvals.
• Support Production Part Approval Process (PPAP) activities.
• Support change control and perform change impact assessments.
• Support SOP and risk documentation updates and reviews.
• Support equipment and process validations.
• Advocate and lead initiatives/projects to enhance quality performance and support compliance to regulations and standards.

Mandatory Requirements

• Bachelor’s degree in an engineering field (e.g., Biomedical Engineering, Mechanical Engineering, or related field).
• 4+ years of industry experience.
• Experience supporting EU-MDR programs/initiatives.
• Excellent English (oral and written).

Nice to Have

• Firm understanding of medical device concepts.
• Familiarity with ISO 13485 and EU Regulations; GDP/GMP concepts.
• Knowledge of risk-based and statistical concepts.